VenUS II: larval therapy Venous Ulcer Study
| ISRCTN | ISRCTN55114812 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55114812 |
| Secondary identifying numbers | HTA 01/41/04 |
- Submission date
- 18/06/2004
- Registration date
- 18/06/2004
- Last edited
- 08/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Nicky Cullum
Scientific
Scientific
Dept of Health Sciences
SRB (Area 2)
University of York
Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321343 |
|---|---|
| nac2@york.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | VenUS II |
| Study objectives | Non-healing leg ulcers are common, costly to the NHS and distressing for patients. Many leg ulcers contain slough and necrotic tissue and, whilst removal of these tissues (debridement) is widely thought to contribute to healing, direct evidence is lacking. Larval therapy has been proposed as a quick and effective debridement strategy and is increasingly used in the NHS, mainly by nurses. Larval therapy may achieve debridement more swiftly than modern wound dressings, which promote a moist environment aiding self debridement, and, unlike surgical debridement, larval therapy use is not reliant on highly trained personnel or the fitness of the patient for surgery. A further benefit of larval therapy, namely the removal of wound bacteria and Methicillin-Resistant Staphylococcus Aureas (MRSA) in particular, has been suggested, but robust evidence of this is also required. This study will establish the cost-effectiveness of larval therapy in the healing of venous and mixed arterial/venous leg ulcers; it will also assess the impact of larval therapy on wound microbiology, including MRSA, and the acceptability of the treatment for patients. Please note that, as of 16 January 2008, the anticipated end date of this trial has been updated from 30 June 2007 to 30 April 2008. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Venous and mixed aetiology leg ulcers |
| Intervention | 3 armed trial: Larval therapy (loose and bagged) and Purilon hydrogel |
| Intervention type | Other |
| Primary outcome measure | Added 10/07/08: Time to healing of reference ulcer |
| Secondary outcome measures | Added 10/07/08: 1. Time to debridement of reference ulcer 2. Health related quality of life 3. Bacterial load (including MRSA) 4. Adverse event data 5. Costs of leg ulcer treatments |
| Overall study start date | 01/09/2003 |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Added 10/07/08: 370 patients |
| Key inclusion criteria | Adults over 18 years old with leg uclers containing slough and/or necrotic tissue |
| Key exclusion criteria | Does not comply with inclusion criteria |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 30/04/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dept of Health Sciences
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Sponsor information
University of York (UK)
University/education
University/education
Heslington
York
YO10 5DD
England
United Kingdom
| Website | http://www.york.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | cost-effectiveness results | 19/03/2009 | Yes | No | |
| Results article | results | 19/03/2009 | Yes | No | |
| Other publications | HTA report | 01/11/2009 | Yes | No |
